Post-Market Surveillance Engineer – Medical Devices

Pure Global; Aliso Viejo (CA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

RxSight is seeking a Post Market Surveillance Engineer to conduct technical complaint investigations and post-market analyses that support regulatory compliance and patient safety.

You will apply risk management and root cause analysis to ophthalmic implants, instruments, and related products, working with Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical Affairs to ensure timely, compliant resolutions.

Qualifikationen

• Bachelor’s degree in engineering; Biomedical Engineering preferred.
• Experience with root cause analysis and risk management.
• Familiarity with regulatory documentation and technical reporting.
• 2+ years in quality systems within medical devices or regulated industries.

Aufgaben

• Perform complaint product analysis, testing, and evaluation per internal procedures and regulatory requirements.
• Execute bench/lab testing to support investigations, develop or refine test methods.
• Conduct root cause investigations using engineering problem-solving techniques.
• Perform risk assessments, trend analysis, and history reviews of complaints.

Kenntnisse

Strong verbal and written comms

Organizational & time management

Data analysis & data synthesis

Cross-functional collaboration

Problem solving & RCA

Ausbildung

Bachelor’s degree in engineering (Biomedical Engineering preferred)

Tools

CAD

Engineering drawings

GD&T

Lab instrumentation

Jobbeschreibung

RxSight is seeking a Post Market Surveillance Engineer to conduct technical complaint investigations and post-market analyses that support regulatory compliance and patient safety.

You will apply risk management and root cause analysis to ophthalmic implants, instruments, and related products, working with Engineering, Quality, Regulatory, Manufacturing, Customer Service, and Clinical Affairs to ensure timely, compliant resolutions.